Have you been wondering what has been going on with the Unique Device Identification program that the FDA is in the process of introducing? You are not alone, there has been very little news on the program and many in the Auto ID industry have been thinking that the idea is being dropped. There is […]
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UDI Goes Global
The FDA is expected to finalize its Unique Device Identification (UDI) regulation requirements before June of this year. While the medical device industry awaits these regulations, the Global Harmonization Task Force (GHTF) has gone ahead and released a draft guidance proposal for a UDI system that can be used worldwide. The GHTF is a volunteer group of […]
Printing GS1 Datamatrix for UDI Applications
If you are involved with manufacturing medical devices, you’ll be aware of the proposed new Unique Device Identification (UDI) rules from the FDA. One elegant way to handle this is to use the GS1 version of the Datamatrix code to add all of the required information to your labels. Want to learn how? Why not […]
Should You Have A UDI System Now?
Last month, the UDI conference was held in Baltimore, MD. to educated medical device manufacturers about the the mandatory FDA rule coming in late 2011. The FDA Unique Device Identification (UDI) Rule will establish a single device identification system that is consistent, unambiguous, standardized, and global. All manufacturers of medical devices will be required to […]
GS1 Datamatrix Barcode and UDI
The GS1 128 barcode has become a standard in many industries for allowing data to be encoded into barcodes using standard formats so that the data can be used in applications all over the world. It has become a standard tool for organizations wanting to improve their supply chain visibility. Probably the biggest downside to […]
UDI-FDA Ruling Webinar
Currently there is no effective way for manufacturers, healthcare distributors and hospitals to handle recalls or traceability which could effect patient safety. The FDA is continuing to move forward with the UDI ruling as a way to identify a particular medical device within the United States. through distribution and use. The Unique Identifier will be […]
Why talk UDI with us at BIOMEDevice Show
Although the UDI rule will not become mandatory until 2013, this is a good time to start thinking about what changes you need to make to your labeling and data processes. Advanced planning and readiness now can better prepare you for action when the mandate is activated. Winco ID is going to be exhibiting at […]
Launch Date for UDI System Set
The FDA’s Center for Devices and Radiological Health (CDRH) has set a time line for release of the Unique Device Identification system. By September 30, 2013, the CDRH says it will launch the system for identifying and tracking all medical devices. One of the CDRH’s responsibilities includes regulating firms who manufacture, repackage, relabel, and/or import […]
Discussion of UDI Particulars Underway
The Global Harmonization Task Force (GHTF) is a group of representatives from medical device regulatory agencies and the medical industry. GHTF has released a discussion paper on UDI for medical devices and hopes to prepare a draft of guidelines for Unique Device Identification soon. Currently there is no definition of a worldwide UDI tracking mechanism, […]
Update on UDI Implementation
The FDA sought detailed feedback from medical device manufactures and hospitals on a unique device identification database (UDID) prototype recently. A pilot study, conducted in August of 2009, was done to determine the feasibility of collecting and storing UDI data from the supplier to the product’s point of use at five hospitals. The study included data on 621 […]